The Principal Lead Data Manager plays a central role in managing clinical data across assigned studies, acting as the primary liaison between project teams, clients, and external vendors. This position oversees all phases of data management, ensuring accuracy and compliance from electronic data capture (EDC) design through final database closure and delivery of data outputs.
Key Responsibilities
- Serve as the main contact for data management inquiries from internal departments, clients, and third parties
- Lead and supervise data management activities across multiple studies, ensuring adherence to timelines, protocols, and regulatory standards
- Coordinate EDC development, data collection, cleaning, reconciliation, and final database lock processes
- Contribute to the creation and review of study-specific documentation, including data management plans and specifications
- Perform user acceptance testing, manage user access, and oversee query resolution and data review processes
- Support serious adverse event (SAE) reconciliation and external data integration
- Generate data listings and patient profiles, and ensure final deliverables meet quality requirements
- Maintain and audit quality control for electronic trial master files (eTMF) and data management working documents
- Participate in internal and client-led audits, supporting inspection readiness and follow-up on findings
- Train and mentor data management staff, including Lead and Assistant Data Managers
- Deliver study-specific training to clinical teams on case report form (CRF) completion and present at investigator meetings
- Support business development through proposal input and contribute to departmental process optimization initiatives
Additional Contributions
This role also involves monitoring project scope, budget, and deliverables, providing strategic input to ensure efficient execution. The Principal Lead Data Manager supports continuous improvement in data management practices and helps maintain high standards across all stages of clinical trial data handling.
